Ocular Surface Disease Changes After iStent or iStent Inject Implantation With Phacoemulsification
Completed · Not applicable
Conditions studied: Ocular Surface Disease, Glaucoma, Open-Angle
In brief
This prospective interventional single-arm trial evaluates measures changes in ocular surface disease parameters in eyes with mild to moderate open-angle glaucoma (OAG) on 1-4 glaucoma medications who undergo phacoemulsification and trabecular micro-bypass stent(s) implantation (iStent or iStent inject).
Key facts
- Study ID
- NCT04452279
- Run by
- Vance Thompson Vision
- People needed
- 47
- Starts
- 2018-05-01
- Expected to finish
- 2019-08-15
- Last updated by the study team
- 2020-06-30
Who can join
Age: 22 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Mild to moderate primary open-angle glaucoma
- Currently treated with ocular hypotensive medication
- Primary open-angle, pseudoexfoliative and pigmentary glaucoma are acceptable diagnoses
- Subject scheduled to undergo cataract surgery in combination with one trabecular meshwork bypass stent
- 22 years of age or older
- Able and willing to attend scheduled follow-up exams for three months postoperatively
- Able and willing to provide written informed consent on the IRB approved Informed Consent Form
- Successful, uncomplicated cataract surgery
- OSDI of 8 or more
You may not qualify if…
- 1. Primary angle-closure glaucoma; or secondary angle closure glaucoma, including neovascular glaucoma 2. Any pathology for which, in the investigator's judgement, the following would be either at risk or contraindicated:
- Cataract surgery
- Stent implantation
- Compliance to elements of the study protocol (e.g., ophthalmic examinations, follow-up visits) 3. Fellow eye actively enrolled in this trial 4. Current participation in any study, or participation within 30 calendar days of screening exam 5. Unsuccessful, complicated cataract surgery 6. OSDI of 7 or less
Where it is running
- Vance Thompson Vision — Sioux Falls, South Dakota, United States
Full record on ClinicalTrials.gov
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